Those who import FDA regulated products to the US need to be very meticulous in planning their activity. If they get any of these aspects wrong-registration, product compliance, record and data submission-their product can be detained.
Likewise, the requirements set out by the U.S. Customs and Border Protection (CBP) must be completely precise, failing which an importer’s item could get aborted before it enters US shores. While it is common for importers to make certain kinds of errors, most others accrue from a lack of understanding of how FDA and Customs and Border Protection (CBP) operate their joint program.
Importers should realize that any decision they take regarding the logistical aspects of importing products comes with its own set of consequences. They could end up coughing huge amounts of money, apart from the time they will have to spend in securing the release of their detained products.
This becomes all the more frequent if they do not know how to work with the FDA. Knowledge is a core factor there. For instance, being aware of the fact that they are not allowed to appeal if their entry is refused, or of the fact that they could face the prospect of attracting additional steep fines by CBP and get blocked from the U.S. market can go a long way in alleviating their problems.
It is knowledge of this kind that a webinar being organized on March 24 by GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is going to impart. This webinar, titled “6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020”, will have Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, as the expert.
Please enroll for this learning by visiting globalcompliancepanel .
Most problems concerning imports to the US market arise because importing firms are not aware of the ways of preparing, conducting and reporting information in a manner that meets the FDA’s requirements. The truth is that the FDA is more than willing to help importers who meet their requirements, but is equally harsh and unforgiving on those that don’t.
So, the basis to operating an import business and profit from the US market is to comply with the FDA regulations. Importers need to grasp the FDA’s and CBP’s import program, which is what this webinar will familiarize its participants with.
Casper will cover the following areas at this session:
- FDA’s legal authority and burden of proof
- FDA registration, product information and the software PREDICT screening program
- CBP entry information and the Automated Commercial Environment (ACE) program
- Tariffs, fees, bonded warehouses, and free trade zones (FTZ)
- Special labeling requirements, e.g., bulk active pharmaceuticals, research use, investigational use, and return for repair
- FDA “holds,” “detentions” and what to do immediately
- Negotiating with FDA
About the speaker:
Casper Uldriks, who owns the firm, Encore Insight LLC, specialized in the FDA’s medical device program as a field investigator, and served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements.
Over 32 years of having worked with the FDA, he understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.